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Peripheral Artery Disease and Sepsis Outcomes

Prevalence and Outcomes of Peripheral Artery Disease in Sepsis Patients in the Medical Intensive Care Unit

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03372330
Enrollment
200
Registered
2017-12-13
Start date
2017-09-11
Completion date
2019-09-10
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Peripheral Artery Disease, Peripheral Artery Occlusion, Sepsis

Keywords

peripheral artery disease, sepsis

Brief summary

The peripheral artery disease (PAD) prevalence is high in the elderly, the diabetic patients, and the patients receiving hemodialysis. To date, there is no guideline recommendation on the screening of PAD in patients admitted to the medical intensive care unit (MICU) for sepsis. We conducted a prospective cohort study focusing on patients admitted to the MICU with the main diagnosis of sepsis. The ankle-brachial indexes are performed within 24 hours after admission. Invasive arterial line monitoring and standard non-invasive measurements are collected. After confirmation of PAD, standard anti-platelet treatments (aspirin and cilostazol) are initiated. The survival before and after the conduction of this trial is compared to historical records. The outcomes including all-cause mortality, stroke, myocardial infarction, minor amputation, major amputation, and prolonged ventilator dependent are to be collected.

Detailed description

This is a prospective observational study focusing on peripheral artery disease (PAD) in patients admitting to intensive care units with a diagnosis of sepsis. The sepsis is defined by the quick SOFA score. The primary outcome is all-cause mortality. The secondary outcomes included stroke, myocardial infarction, amputation, and prolonged mechanical ventilation. We plan to enroll 150 patients. Patients will be grouped into patients with PAD and patients without PAD. We then compare them in the following parameters: clinical data, laboratory data, survival and other outcome data. Two-sample student's t-tests will be used for the comparisons of continuous variables. Chi-square test will be used to detect the difference between categorical variables. The difference is considered statistically significant if P \< 0.05. All statistics works were analyzed using the SPSS 17.0 software (Chicago, IL, USA), R software (Gimc packages).

Interventions

DRUGStandard care for sepsis and PAD

The standard medications care for the patient with PAD included antiplatelet agents.

DRUGStandard care for sepsis

The standard care for the patient with sepsis.

Sponsors

National Taiwan University Hospital Hsin-Chu Branch
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* sepsis patients admitted to the MICU meeting quick SOFA score \>= 2 points

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality at 30-day30 daysAll-cause mortality at 30 days

Secondary

MeasureTime frameDescription
Myocardial infarction30 daysMyocardial infarction at 30 days
Stroke30 daysIschemic stroke at 30 days
Amputation30 daysAmputation, either major or minor at 30 days

Countries

Taiwan

Contacts

Primary ContactMu-Yang Hsieh, MD
drake1128@gmail.com886-972654046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026